09-2 Controlling Suspect Counterfeit Items Procedure Rev001
09-2 Controlling Suspect Counterfeit Items Procedure Rev001
1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
QA
1006
Administrative Procedure
1001
Page 1 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
1.0 Purpose
The purpose of this procedure is to describe the actions necessary to manage Suspect Counterfeit Items (S/CI)
upon discovery.
2.0 Scope
All new and existing items, equipment, products or parts at Fermilab are within the scope of this document.
3.0 Applicability
This procedure applies to Fermilab line management, division/section/center (D/S/C) S/CI Coordinators,
employees, subcontractors, and users, Senior Safety Officers (SSO’s), Laboratory ES&H Committee Chair,
Procurement Department, and the Office of Quality and Best Practices (OQBP).
4.0 Responsibilities
4.9 Procurement
Incorporate technical requirements that are a part of or attached to the relevant requisition into the
subcontract
Contact subcontractor and ensure that Fermilab’s S/CI concerns are documented in Fermilab’s
subcontract file
Note: Fermilab personnel SHALL NOT contact the supplier of a potential S/CI without
concurrence from OQBP.
Note: A nonconforming item is not automatically suspect and should be managed using
existing nonconforming / discrepant items procedures unless there is evidence suggesting
that it meets the definition of a suspect item or counterfeit item in section 7. Appendix II
provides guidance on identification of S/CI.
5.1 An individual identifies a potential S/CI, stops work associated with the S/CI and notifies their
immediate supervisor or other line manager.
5.2 The supervisor/line manager notifies the local Senior Safety Officer (SSO) if there is a risk to ES&H,
segregates S/CI where practicable, and notifies the local D/S/C S/CI Coordinator. The SSO will begin
an investigation to determine the immediate ES&H-related risks the potential S/CI poses.
IF it is not practicable to segregate S/CI (due to the nature of the item or because it is
installed), THEN line management will make provision to ensure that others in the area are
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
made aware of the presence of S/CI. The supervisor/line manager ensures that work
associated with the S/CI is not resumed until an investigation has been conducted and the
S/CI has been dispositioned by engineering or other subject matter expert.
IF the S/CI is installed, THEN notify appropriate management to request assistance with
the investigation from engineering or other subject matter expert. The engineer or other
subject matter expert will determine S/CI disposition, including notifying the SSO of a risk
to ES&H not already reported.
IF notified by a supervisor/line manager, THEN the local SSO follows applicable FESHM
policies and procedures and notifies the local S/CI Coordinator and OQBP if his/her
investigation concludes that there is a safety risk associated with the S/CI.
IF the D/S/C S/CI Coordinator receives a “response required” notice from OQBP of S/CI
discovered elsewhere, THEN he/she will contact the appropriate line management to
ensure an inspection is conducted. IF S/CI is discovered during the inspection THEN the
S/CI Coordinator and line management, ensure that it is managed in accordance with these
procedures.
IF the S/CI notice from OQBP does not indicate “response required”, THEN it is for
awareness only and local management will determine if any action is required.
5.3 The D/S/C S/CI Coordinator ensures that S/CI is segregated or other provisions applied as noted in
step 2, and indicates the S/CI status with an S/CI Tag to prevent further use. Where tagging is not
practicable, application of a “safety purple” paint appropriate for the materials and conditions is
acceptable. The S/CI Coordinator updates and maintains an S/CI log which includes the unique S/CI
log number, pertinent information about the item, including status.
5.3.1 The S/CI Tag has two sides. The S/CI Coordinator completes the side labeled HOLD,
indicates the S/CI log number and reason the item is suspect and contact information. The
other side of the S/CI Tag is reserved for disposition by the responsible engineer or subject
matter expert.
IF the application of an S/CI Tag or paint is not practicable, THEN the D/S/C S/CI
Coordinator will contact OQBP to determine the appropriate action to prevent further use.
An S/CI log number is still assigned and logged even in the event alternative markings are
used as directed by OQBP.
5.4 The D/S/C S/CI Coordinator coordinates the investigation with line management and other staff,
updates and ensures the S/CI log and supporting materials contain adequate information.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
IF the item is not nonconforming relative to the requestor’s requirements, but still
considered to be a potential risk or issue THEN the D/S/C S/CI Coordinator notifies
OQBP. OQBP will determine if further notifications are necessary. Examples include high
strength shackles or high strength bolts with no manufacturer’s code and no clear
purchasing requirement for a manufacturer’s code.
Note: Nonconforming procedures should require identification and quarantine of all like
items.
5.5 The D/S/C S/CI Coordinator and line management (with SME participation, as appropriate) complete
an investigation and reach a conclusion indicating whether the S/CI status is confirmed. Two
conditions must be met to conclude that the S/CI status of an item is confirmed; 1) It must be
nonconforming to requirements specified in procurement documents, and 2) its documentation,
appearance, performance, material, or other characteristics may have been knowingly misrepresented.
See the Definitions section.
IF the status is no longer considered S/CI, THEN continue with existing nonconforming
procedures including disposition by engineering or other subject matter expert.
IF the item is still considered to be a potential risk or issue, although no longer considered
S/CI, THEN the D/S/C S/CI Coordinator notifies OQBP. OQBP will determine if further
notifications are necessary.
IF the status is confirmed S/CI or still in doubt, THEN locate, tag and quarantine all items
with the same item identification from the same procurement. The D/S/C S/CI
Coordinator notifies OQBP and provides copies of supporting materials upon request. In
this case S/CI remains in quarantine pending further instruction from OQBP.
5.6 Disposition of S/CI is recommended by engineering or other subject matter experts based on evaluation
of the likelihood of injury to personnel, damage to the environment, damage to other equipment, and
other technical and operational considerations. The S/CI Coordinator will ensure that OQBP, line
management, and SSO’s are advised of the recommended disposition. The recommended disposition
requires OQBP approval before implementation.
IF the disposition of installed items is other than replace immediately THEN the
responsible engineer or subject matter expert completes the side of the S/CI Tag labeled
DISPOSITION. This side includes a section for “Review date” which must be completed
to indicate when the S/CI issue or the material itself should be re-examined.
Page 5 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Note: It is expected that when S/CI are replaced the S/CI Tag is removed, they are
destroyed, and the S/CI log entry closed out. The exception to S/CI destruction is whether
the OQBP wishes to retain the item for training purposes. In the event where S/CI are
destroyed, disposal must be completed in a manner to prevent reuse and records of
destruction shall be retained. Records are retained by BSS, Property & Inventory Control
in accordance with “Department of Energy Administrative Records schedule 4, Item 1
which established a two-year retention schedule for property disposal records. For offsite
destruction, contact the Business Services Section, Property and Inventory Control
Manager. Destruction of S/CI materials considered hazardous is handled in accordance
with applicable laws, regulations DOE directives and FESHM 8021.
6.0 Records
S/CI Log
Records of disposition
Records of destruction
7.2 Reviewers
OQBP Head
Division/section/center S/CI Coordinators
Procurement Manager
7.3 Approver
OQBP
9.0 Definitions
Counterfeit items are nonconforming items whose documentation, appearance, performance, material, or
other characteristics are knowingly misrepresented by the vendor, supplier, distributor, or manufacturer.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Suspect items are nonconforming items whose documentation, appearance, performance, material, or other
characteristics may have been knowingly misrepresented by the vendor, supplier, distributor, or
manufacturer.
Note: By definition, for an item to be considered S/CI officially it must first be nonconforming to
specified requirements. Therefore all confirmed S/CI are nonconforming items but all
nonconforming items are not necessarily S/CI.
10.0 References
DOE O 414.1C Quality Assurance – Contractor Requirements Document, Attachment 2 Section 4 – DOE-
Wide Suspect/Counterfeit Item Prevention Process
DOE G 414.1-3- Suspect Counterfeit Items Guide
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Risk
Notify local SSO (5.2) Yes
to ES&H? (5.2)
No
Request SME
Prior to use or
SSO review (5.2) assistance in risk No
installation? (5.2)
assessment (5.2)
Yes Yes
S/CI Coordinator
ensures isolation
controls are adequate &
No items are tagged (5.3)
S/CI Coordinator
coordinates
investigation (5.4)
Is
Is item potentially
material
No a risk or an
nonconforming?
issue? (5.4) No
(5.4)
Yes Yes
Conduct local
Is
nonconforming / Record findings and
material confirmed No
discrepant material disposition items.
suspect? (5.5)
process (5.5)
Yes
Page 8 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Industrial types of items, materials, parts, and components that have been counterfeited include, but are not
limited to:
Hoists, as well as other hoisting, lifting, and rigging equipment
Valves, pipe, pipe fittings, plates, couplings, plugs, spacers, nozzles, supports, hangars, and
flanges
Preformed metal, elastomers (O-rings, seals), spare replacement kits from suppliers other than
the original equipment manufacturer, weld-filler material, diesel generator speed governors,
pumps
Fasteners: Metallic screw, nut, bolt, or stud having internal or external threads with a nominal
diameter of 1/4 inch (6 mm) or greater. Washer that is through-hardened or represented as
meeting a consensus standard that calls for through-hardening, and that is grade identification
marked or represented as meeting a consensus standard that requires grade identification
marking. e.g., J429 standard for automotive and related industries - below grade 5 (plus grade
8.1 studs) no grade-mark required. However, all bolts and screws shall bear the manufacturer
identification symbol.
Electrical equipment and devices, including circuit breakers, transformers, fuses, relays,
resistors, capacitors, semiconductors, connectors, switch gear, power supplies, inverters,
transmitters, and motors
Metal plates, bars, shapes, channel members, and other structural items
Welding rods and electrodes
Page 9 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
The listing of commercial grade items that have been counterfeited is extensive. Following is a partial listing:
Batteries: household, camera, and cell-phone
Extension cords
Surge suppressors
Fire extinguishers
Automotive components, including oil filters and brake pads
Computer components, semiconductors, software
Pharmaceuticals
Disclaimer
This appendix provides information on individual components identified as suspect or suspect/counterfeit. Without
additional information, the manufacturers or suppliers identified should not be considered as to have engaged in any
wrongdoing. It is not necessarily a negative reflection on a supplier or manufacturer if their products are reported as
suspect/counterfeit items (S/CI). Reputable manufacturers and suppliers have a vital interest in preventing the
manufacture and distribution of S/CI associated with their names. The supplier or manufacturer may have been
victimized and is pursuing S/CI associated with its products in an aggressive, prudent, and professional manner to
get these items off the market. Therefore, each particular case must be examined on its own merit without making
premature conclusions about the fault or culpability of the manufacturer or supplier whose name is associated with
the S/CI.
The following is an update to the Suspect Item Indicator list found in DOE G 414.1-3 and the DOE
Suspect/Counterfeit Item Awareness Training manual.
I. GENERAL INDICATORS
Visual Inspection
Nameplates, labels, or tags have been altered, photocopied, or painted over; are not secured
well; are unusual in location and method of attaching; have incomplete data; or are missing.
Preprinted labels that show typed entries.
Item has wear marks or scratches on external surfaces.
Obvious attempts at repair or beautification have been made, such as excess painting or wire
brushing; evidence of hand-painting (touch-up), painted stainless steel; non-ferrous metals
(e.g., copper, brass, bronze) are clean and bright indicating recent polishing.
Handmade parts are evident; gaskets are rough-cut; shims and thin metal part edges show
evidence of cutting or dressing by hand tools (filing, hacksaw marks, tin snips, or nippers).
Assembled items fit poorly.
Metallic items are pitted or corroded.
Heat discoloration marks.
Casting markings have been ground off and the item has been re-stamped with other markings.
Configuration is not consistent with other items from the same supplier or varies from that
indicated in supplier literature or drawings.
Inconsistency between vendor (seller or manufacturer) name on the item, and the shipping
container.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Procurement
Quoted price for the item is unusually discounted or low. 3
Unusual disclaimers, or denials, of responsibility for the accuracy of the test results, etc.
The supplier is not a manufacturer’s authorized distributor.
Dimensions of the item are inconsistent with the specification requested on the purchase order,
and those provided by the manufacturer at the time of the shipment.
1 In 2003, more than 66% of goods seized at ports of entry into this country were traced to China. What are
Counterfeiting and Piracy Costing the American Economy. National Chamber Foundation, 2005.
2 Refer to http://www.ul.com/ace/fake.html
3 There have been reports of counterfeiters raising prices to just below OEM levels in order to prevent such
concerns. http://fleetowner.com/mag/fleet_counterfeit_parts_buyer/index.html
Page 11 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
II. DOCUMENTATION
Documentation may be suspect or fraudulent when:
The use of correction fluid or correction tape is evident.
Type style, size, or pitch change is evident.
Documentation is not signed or initialed when required.
It is excessively faded or unclear (indicating multiple, sequential copying), or data is missing.
The name of the document approver, or title, cannot be determined; the document has missing
or illegible signature, initials; the approvers name and signature does not match.
Technical data is inconsistent with code or standard requirements.
Certification or test results are identical between items when normal variations should be
expected.
Document is not traceable to the items procured.
Corrections are not properly lined-out, initialed and dated.
Documentation is not delivered as required on the purchase order, or is in an
unusual format.
Lines on forms are bent, broken, or interrupted indicating data has been deleted or exchanged
by “cut and paste”.
Handwritten entries are on the same document where there is typed or preprinted data.
Text on page ends abruptly and the number of pages conflicts with the transmittal.
Data on a single line is located at different heights.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
The above list was prepared by the U.S. Customs Service after extensive testing of many samples of fasteners from
around the United States. If found, consider any of these headmarks as S/CI.
In many cases, a new counterfeit fastener has roughly the same physical strength as the graded fastener it mimics,
but does not meet the chemical composition or heat treatment requirements specified in consensus standards. As a
result, it will stretch, exhibit metal fatigue, or corrode under less harsh service than the genuine fastener.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Fasteners - Bolts.
Suspect/Counterfeit SAE Grade 5 (ASTM A 449) bolts. (Photo on left) From the left -the first three are missing the
required manufacturer’s symbol, and the fourth bolt has the “KS”, Kosaka Kogyo insignia. All four are on the
DOE S/C bolt headmark list (Enclosure 1). (Photo on right) failed fork lift bolt.
Circuit Breakers.
Suspect indicators – missing information
Left – Used 600 volt, 100 amp breaker sold as “new”. Right – Original breaker
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Fuses.
S/CI - Used internal components within 600 volt, 100 amp breaker sold as “new and unused”.
Hook, lifting.
S/CI - Altered working load limit (WLL) marking.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Shackle.
Counterfeit on right. Authentic Crosby on left. a) Crosby name embossed per Crosby logo, b) should see CE mark,
c) 45-degree angle markings, d) pin stamped on head with traceable ID number (www.imca-int.com/safetyflashes)
Shackle.
S/CI – Trademark violation. 6-1/2 Ton rated screw pin shackle, minus any manufacturer’s name or logo, and
country of origin. The red colored screw pin is a Crosby Group trademark.
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SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Flange.
Suspect indicator - Hand stamping
Flange.
Suspect Indicator – Meaningless information; ASA is a reference to an obsolete
consensus standards organization.
Page 17 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Label.
Suspect indicator - Worn label with missing information on a “new” air-dryer valve.
Valve, internal.
S/CI - Internal corrosion of an air-dryer valve sold as “new”.
Page 18 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Extension cords. S/CI - Underwriters Laboratories (UL) Inc. issued an alert regarding 25 and 50 ft. cords. The cords
are marked as UL listed and having 14 gauge wire. These have not been approved by UL and the wire size is
actually significantly undersized, leading to potential fire hazards. http://www.ul.com/newsroom/notices.html
Sprinkler heads, fire protection. S/CI - UL issued two alerts in 2006 regarding Chinese manufactured sprinkler
heads having counterfeit UL marks. http://www.ul.com/newsroom/notices.html
Page 19 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Batteries.
S/CI – “Copper Top” trademark violation and confusingly similar name of the manufacturer “Duracell”.
Counterfeit batteries present a higher risk of malfunction; constructed without adequate vent holes (safety
feature), and often contain mercury - a heavy metal that damages the central nervous system when ingested and
can harm the environment when the batteries are discarded
Page 20 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
Table of Revisions
Author Description Revision Date
Jed Heyes Draft with most formatting changes accepted. A1 000 A3 07/18/08
to A2 Updated draft – eliminated intermediate
form, replaced with S/CI log only – changed
initiation of log to S/CI Coordinator. Updated
name and number scheme. Other changes noted
with change tracking on. A2 to A3 reconcile
OQBP comments.
Jed Heyes Final reconciliation and promotion 000 B 07/23/08
Jed Heyes Updated for lab safety subcommittee role. 000 B1 08/19/08
Clarified when response to OQBP notices are
required
Jed Heyes, Kurt Mohr Updated based on formatting comments from 000 B2 11/07/08
Business Services Section & Jeff Cotton &
consistency with revisions to the S/CI Program.
Kurt Mohr Changed Sect. 8 (Policy and Program) reference 000 B3 11/13/08
to “FIQMP” to “IQA”
Kurt Mohr Revised for consistency with SCI Program based 000 B4 12/9/08
on S/CI team review
Kurt Mohr Revised for consistency with S/CI Program, 000 B5 12/10/08
changes based on input from Joe Collins & Greg
Mitchell
Kurt Mohr Revised Appendix 1 flowchart for consistency 000 B6 12/15/09
with rev B4 & B5 changes. Added allowance for
painting as S/CI identification method and OQBP
approval of disposition recommendation
Kurt Mohr Minor revisions based on S/CI Coordinator 000 B7 1/26/10
reviews 12/09
Kurt Mohr, Jed Heyes Minor revisions based on S/CI Coordinator 000 C 3/16/10
Meeting 1/27/10 and:
Revised list of those with program responsibilities
in 3.0 Applicability. Clarified supervisory role for
program flowdown and expanded application to
Construction Coordinators & Task Managers in
4.5. Relocated paragraphs regarding OQBP
“response required” notification from 5.3.1 to 5.2.
Clarified example in 5.4. Changed initial
notification path to insert OQBP before full
Coordinator notification in 5.4 & 5.5. Added
SME’s to investigating team in 5.5. In 5.6 -
Specified completion of “review date” section of
tag, records retention responsibilities & disposal
of hazardous S/CI material.
7.2 Updated following input from Bruce
Chrisman
Page 21 of 22
SUBJECT: Controlling Suspect/Counterfeit Items Procedure NUMBER: 1006.1001
RESPONSIBILITY: Quality Assurance Manager REVISION: 001
APPROVED BY: Head, Office of Quality and Best Practices EFFECTIVE: 03/19/2010
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